A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

King Faisal Specialist Hospital & Research Center1 site in 1 country120 target enrollmentNovember 2011

ConditionsMalignant Salivary Gland Tumors

DrugsCisplatin: 40 mg/m2 weekly during radiation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malignant Salivary Gland Tumors
Sponsor: King Faisal Specialist Hospital & Research Center
Enrollment: 120
Locations: 1
Primary Endpoint: Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

November 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

King Faisal Specialist Hospital & Research Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma or high grade adenocarcinoma;
•Surgical resection with curative intent within 8 weeks prior to registration;
•Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically positive surgical margin (AJCC, 7th ed.; see Appendix IV); patients must be free of distant metastases based upon the following minimum diagnostic workup:
•Zubrod Performance Status 0-1; 3.1.5 Age ≥ 18; 3.1.6 CBC/differential obtained within 4 weeks prior to registration, with adequate bone marrow function 3.1.7 Adequate renal and hepatic function within 4 weeks prior to registration 3.1.8 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; 3.1.9 Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment. 3.1.10 Patients must be deemed able to comply with the treatment plan and follow-up schedule.

Exclusion Criteria

•3.2.1 Patients with residual macroscopic disease after surgery; 3.2.2 Patients with salivary gland malignancies originating from the minor salivary glands; 3.2.3 Patients with histologies other than high grade mucoepidermoid carcinoma, high grade adenocarcinoma or salivary duct carcinoma; 3.2.4 Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); 3.2.5 Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable; 3.2.6 Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 3.2.7 Severe, active co-morbidity, defined as follows: 3.2.7.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.7.2 Transmural myocardial infarction within the last 6 months; 3.2.7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 3.2.7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol. 3.2.7.6 Acquired Immune Deficiency Syndrome (AIDS) 3.2.7.7 Pre-existing ≥ grade 2 neuropathy; 3.2.7.8 Prior organ transplant. 3.2.8 Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary; 3.2.9 Significant pre-existing hearing loss, as defined by the patient or treating physician.